Safety and immunogenicity of a paediatric presentation of an influenza vaccine

Arch Dis Child. 2000 Dec;83(6):488-91. doi: 10.1136/adc.83.6.488.

Abstract

Background: Flu vaccination in otherwise healthy infants and young children is important to prevent severe disease, as well as to control epidemic spread of influenza infection.

Aims: To examine the safety and immunogenicity of a paediatric presentation of a purified, inactivated, triton split influenza vaccine.

Methods: Two doses of the vaccine, provided in prefilled syringes of 0.25 ml, were administered, one month apart, to 67 children under 3 years of age.

Results: Nine cases of immediate reaction to vaccination (macules/papules) were observed after the second injection only. During the study period, 9% of children experienced at least one delayed local reaction, and 28% of children presented at least one systemic reaction. Almost all reactions were mild and transient. Immunogenicity results surpassed the European Community recommendations for a 0.50 ml dose of vaccine in adults.

Conclusion: This paediatric formulation of inactivated flu vaccine appears safe and immunogenic in children from 6 months to 3 years of age; the convenient presentation in a prefilled syringe of 0.25 ml volume will facilitate administration of the dose recommended for young children.

Publication types

  • Clinical Trial

MeSH terms

  • Antibodies, Viral / biosynthesis
  • Child, Preschool
  • Female
  • Hemagglutination Inhibition Tests
  • Humans
  • Infant
  • Influenza A virus / immunology
  • Influenza B virus / immunology
  • Influenza Vaccines / adverse effects*
  • Influenza Vaccines / immunology
  • Influenza, Human / prevention & control*
  • Male
  • Vaccination / adverse effects
  • Vaccines, Inactivated / adverse effects*
  • Vaccines, Inactivated / immunology

Substances

  • Antibodies, Viral
  • Influenza Vaccines
  • Vaccines, Inactivated